RecruitingACTRN12622000987763

Establishment of the National Endometriosis Clinical and Scientific Trials (NECST) Registry to study the life course and impact on quality of life of people living with endometriosis.

Establishment of the National Endometriosis Clinical and Scientific Trials (NECST) Network Registry

Sponsor

UNSW

Enrollment

5,000 participants

Start Date

Dec 8, 2020

Study Type

Observational

Conditions

Persistent pelvic pain Benign gynaecology Fertility Endometriosis Adenomyosis Chronic pelvic pain

Summary

The project is part of a national collaborative project by Australian clinicians and researchers, the National Endometriosis Clinical and Scientific Trials (NECST) Network. The NECST Registry will be a national resource of participant data that will facilitate high quality research aiming to understand the causes of endometriosis, improve diagnosis and treatment outcomes, and reduce the burden of disease for patients with endometriosis-related symptoms or diagnosed with endometriosis. Currently, there is a lack of clinical data about endometriosis. This is why there can be a delay of 7 – 12 years before a diagnosis of endometriosis is made for some people. In addition, clear care management plans are not yet available due to the lack of understanding of how endometriosis develops or changes during a woman’s lifetime. The NECST Registry will collect and securely store demographic and health related information from consenting participants, who experience and/or seek management for endometriosis and/or endometriosis-related symptoms or conditions (e,g., adenomyosis).

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Endometriosis is a condition where tissue similar to the lining of the uterus grows outside of it — on the ovaries, fallopian tubes, or elsewhere in the pelvis. It can cause chronic pelvic pain, painful periods, pain during sex, and fertility problems. Shockingly, it can take 7–12 years from first symptoms to a confirmed diagnosis, largely because of how little is understood about the condition's causes and progression. The NECST Registry is a national Australian initiative to change this by collecting detailed health information from people with endometriosis or related conditions like adenomyosis over their lifetime. This long-term data will help researchers understand how endometriosis develops, find better diagnostic tools, and improve treatment options for the millions of Australians affected. You may be eligible if you are an Australian resident, are 18 or older, speak English, and either have surgically confirmed endometriosis or adenomyosis, or experience symptoms that may be related — such as persistent pelvic pain, heavy periods, pain with bowel movements or urination, pain during sex, or difficulty falling pregnant. Participating involves completing surveys about your health and experiences.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The NECST Registry aims to collect prospective and longitudinal health data to understand the causes and life course of endometriosis, improve diagnosis and treatment outcomes, and reduce the burden of disease for patients with endometriosis-related symptoms or diagnosed with endometriosis. Eligible women will be invited to participate by a clinician at a participating site during their appointment (either face-to-face or telehealth). Interested and consenting women will be asked to complete the following questionnaires (online): At baseline (duration of questionnaires: 25 - 35 mins) 1. Consent and demographics 2. Clinical presentation and medical history 3. Patient-reported outcome measures (PROMs; and are validated tools) 3a. Euroqol (EQ)-5D-5L (general quality of life questionnaire) and/or 3b. Endometriosis Health Profile (EHP)-30 (endometriosis-specific questionnaire and for women with this diagnosis) Follow up questionnaires (at time points: 6 months, 12 months and annually thereafter; duration of questionnaires: 10 - 15 mins) 4a. Clinical presentation and medical history (short version) and 4b. EQ-5D and/or 4c. EHP-30 Participating women will be followed up until 1. participant withdraws from the study or 2. participant is lost to follow up or 3. funding to maintain the NECST Registry is discontinued. Clinicians will be requested to enter data, dependent on the management and treatment plan for the woman. Data collected are under the following modules: 1. Clinical presentation - Diagnosis (mandatory module to be completed) 2. Imaging (including report) 3. Medical treatment 4. Surgical treatment 5. Histopathology (including report) - Clinicians will upload or enter data into the registry when an imaging scan is performed, there is a change to the medical treatment plan or when surgery is indicated for each participant they care for until 1. participant withdraws from the study or 2. participant is lost to follow up or 3. funding to maintain the NECST Registry is discontinued.